drugset / Trial / NCT01034995

A Trial Evaluating the Efficacy and Tolerability of SSR125543 in Outpatients With Major Depressive Disorder

NCT01034995

Phase 2 Completed 580 enrolled Sanofi
RandomizedParallel-groupTriple-blindTreatment

Summary

Primary Objective: * To evaluate the efficacy of three fixed doses of SSR125543 (20 mg daily, 50 mg daily, and 100 mg daily) compared to placebo in outpatients with major depressive disorder, as assessed by the change from baseline (Day -1) to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score. Secondary Objectives: * To evaluate the tolerability and safety of SSR125543 in outpatients with major depressive disorder * To evaluate plasma concentrations of SSR125543

Timeline

Start
2010-02
Primary completion
2011-03
Completion
2011-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Crinecerfont Small molecule 20 mg Oral
Subject Crinecerfont Small molecule 50 mg Oral
Subject Crinecerfont Small molecule 100 mg Oral
Comparator Escitalopram Small molecule 10 mg Oral